We had an overwhelming response to our May 2014 webinar on the topic of Strategic Patient Screening. As a follow up, here are answers to some of the most popular questions related to the patient pre-screening process. Read answers to the budget and feasibility related questions here.
Q: How much data can be put out on the web in terms of I/E criteria?
I am not aware of any specific regulatory guidelines or restrictions per se, although the postings on www.clinicaltrials.gov provide a good frame of reference. If the intent is to help a potential subject pre-screen themselves to see if they might qualify for a trial, then one should apply the same “strategic segmentation” process described in the webinar. The goal is to quickly help a subject rule himself or herself out of further consideration so the top or core eligibility criteria would be a good starting point. This may be in the range of 5-15 criteria but it should be easy for the prospective subject to answer based on their known conditions. If it is too time consuming or cumbersome for the patient to complete the pre-screening self-assessment, they may become discouraged or frustrated. While it goes without saying that any information in the public domain must be approved by the IRB/Ethics Committee, it is important to set appropriate expectations with the prospective subject about additional pre-screening and screening requirements that they will undergo to determine their eligibility in the trial. Further, for patients who fail the initial online pre-screening, it is important to provide other resources where they can go for further information so their interest in participating in clinical research is not wasted.
Q: Do you have a suggestion on how to design HIPAA risk-free “Pt Qualifying Checklist” of eligibility criteria and patients data that substantiates “qualifies” for one study or multiple studies?
I am not sure if I completely understand this question and terminology related to HIPAA “risk free”. As a general rule, conducting any type of enrollment validation or pre-screening EMR, database or chart review work would necessarily need to comply with the institution’s “review preparatory to research” guidelines. The HIPAA provisions allow for this work to be done. However, different organizations and IRBs have different interpretations for what type of preparatory work can be done with and without “generic” or “study specific” HIPAA authorizations. It also depends on the relationship of the person conducting the review vis-à-vis the covered entity who holds the data.
So, at the risk of avoiding the question entirely, it may be helpful to review some of the “basics” about preparatory research at the links below and to re-visit your existing policies to determine if revisions to your current checklists and processes can support some of the pre-screening or enrollment validation work. This link provides key references related to the preparatory research provision of HIPAA.
Q: How do sites actually screen/enroll subjects? The presentation seemed to be more oriented towards budget planning and pre-screening…not enrollment of eligible subjects on therapeutic trials?
Certainly, understanding the financial ramifications related to pre-screening and screening is important to ensure that the work effort involved to identify and evaluate subjects is appropriately compensated. Without sufficient funding, sites can get fatigued, enrollment can languish, and then the precious contribution of the subjects who have enrolled is potentially wasted if trials aren’t completed in a timely manner.
Having said that, the focus of a “strategic patient screening” process is to follow the methodology of segmenting the protocol eligibility criteria into pre-screening and screening “buckets.” In other words, mapping out which inclusion and which exclusion criteria can be determined at pre-screening (i.e., pre-consent) via an EMR search or chart review versus those criteria that can only be determined post consent.
From there, the next sort is to determine which criteria can be quickly determined (e.g., by a medical assistant) versus which criteria will take more time or expertise to evaluate. The top left box in the segmentation grid below captures the “core criteria” that can quickly be used to rule a patient out from further participation.
The criteria can then be translated into a job aid (e.g., excel or other worksheet, of which several examples were shown in the webinar). The job aid is what is used to guide the actual pre-screening process. For example, using a worksheet such as the illustrated example below provides the road map for efficiently evaluating a potential candidate:
- First assess the core inclusion criteria (the quick and easy from the segmentation activity). If the patient passes this criteria then…
- Evaluate any permanent exclusions that could rule a patient out. If the patient has NO permanent exclusions then…
- Assess whether the patient has any of the “transient” exclusions (i.e., the criteria that are associated with a given time line such as recent infections, or amount of time on a stable dose of medication).
- If the patient has any transient exclusions, add them to a “watch and wait” list and follow-up with the patient at the appropriate time frame to re-evaluate their eligibility
- If the patient has NO transient exclusions, then this would be a pre-qualified patient who could be approached about the study to explore their interest. Upon receiving appropriate informed consent, the remaining screening criteria could be evaluated (along with verification that nothing has changed based upon the pre-screening evaluation).